Diamond Therapeutics Inc. (Diamond), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, commended Health Canada's decision to reverse regulatory changes made to the Special Access Program (SAP) in 2013 that prohibited access to restricted drugs, including psilocybin.
The purpose of the SAP is to afford Canadians with serious or life-threatening conditions access to emerging, potentially life-saving medications prior to their formal approval. This amendment will allow physicians to request access to restricted drugs on a case-by-case basis when other therapies have failed and where there is sufficient evidence of safety and efficacy for the treatment of the patient's condition. Health Canada's decision may offer patients who have not responded to existing therapies new avenues to receive care.
"Together with our partner Dalton Pharma Services we are carefully evaluating how the recent change to the Special Access Program may permit us to assist those in need," says Diamond CEO Judy Blumstock.
Diamond echoes Health Canada's ongoing stance that clinical trials remain the best mechanism to expand treatment options by generating scientific evidence that can lead to the approval of efficacious new drugs.
"At Diamond, we feel strongly about the need to broaden access to psilocybin safely and responsibly through a rigorous clinical trial process," says Blumstock.
In November 2021, Diamond commenced a Health Canada-approved clinical trial to evaluate the pharmacokinetics and pharmacodynamics of low doses of psilocybin in healthy volunteers. The study is ongoing.
The psilocybin active pharmaceutical ingredient used in this trial was manufactured by Dalton Pharma Services, which has an exclusive worldwide partnership with Diamond to provide psilocybin to support clinical trials, research, and future commercial opportunities.
Dalton is one of only a few Canadian companies to have successfully manufactured cGMP psilocybin for use in an approved clinical trial. Dalton has already produced cGMP psilocybin in sufficient quantities for Diamond's planned Phase 2 clinical trials and research needs.
About Dalton Pharma Services
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development, and manufacturing services. It is FDA-registered, and Health Canada approved and bring over 30 years of experience to every project. It delivers fully integrated solutions with an emphasis on speed, flexibility, and quality. Its integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing, and Accelerated Stability Testing) all at one location help it to be adaptable, flexible and cost-effective.
To learn more about Dalton's history and capabilities, please visit dalton.com.
About Diamond Therapeutics
Diamond Therapeutics is a drug development company based in Toronto, Ontario. Its mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort—maximizing the positive impact better drugs can have on global mental health.
To learn more about Diamond, visit diamondthera.com.
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